Overview
- 6 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-09-13.
At a glance
Inspections
6
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 9 Sep 2024 – 13 Sep 2024 | Medical Devices & Rad Health | 483 | View 483 → |
| 24 May 2022 – 13 Jun 2022 | Medical Devices & Rad Health | 483 | View 483 → |
| 29 Sep 2016 – 10 Nov 2016 | Medical Devices & Rad Health | 483 | View 483 → |
| 18 Sep 2012 | Not recorded | 483 | On file |
| 17 Dec 2010 | Not recorded | Clean | |
| 26 Apr 2006 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
13 Jun 2022
21 CFR 820.30(g)
Design Validation - Risk analysis not performed/inadequate
Cited by Nicholas T Domer
Investigators
FDA investigators tied to this site in the record.
Michelle J Glembin2 insp.
Corey K Reno2 insp.
Albert L Nguyen1 insp.
Nicholas T Domer1 insp.
Aaron L Dunbar1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.50(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 803.18(b)(1)(i) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.60 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.80(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 803.50(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Zoll Medical Corporation's 4 Form 483s
Source PDFs and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat